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Certification reference for suppliers of feed materials– V1 December 2019 Page 1 | 38 Certification Standard: Suppliers of processed feed materials for use in the production of animal feed RCF 1 December 2019

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Page 1: Suppliers of processed feed materials for use in the production of … · For oPRP, monitoring should be regular but is not necessarily permanent. Note of French authorities DGAL/SDSSA/N2012-8156

Certification reference for suppliers of feed materials– V1 December 2019 Page 1 | 38

Certification

Standard:

Suppliers of processed feed

materials for use in the production

of animal feed

RCF

1 December 2019

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Table of contents

Section 1 Introduction .......................................................................................................................................... 3

1. General information ................................................................................................................................. 3

2. Scope of application ................................................................................................................................ 3

3. Terms and Definitions .............................................................................................................................. 3

Section 2 Management Responsibility ................................................................................................................ 7

1. Commitment and Feed Safety Policy for animal feed ............................................................................. 7

2. Management system for animal feed safety ............................................................................................ 7

3. Responsibility and authority ..................................................................................................................... 8

4. Management of emergency situations (alerts / crises): ........................................................................... 8

5. Management review ................................................................................................................................ 8

Section 3 Management of animal feed safety ..................................................................................................... 8

1. General documentary requirements ........................................................................................................ 8

2. Regulatory monitoring .............................................................................................................................. 9

3. Identification and Traceability .................................................................................................................. 9

4. Hazard analysis according to the 7 principles of the HACCP method .................................................... 9

4.1 Principle 1: .............................................................................................................................................. 9

5. Verification (internal audits, analysis plans) .......................................................................................... 11

6. Management of non-compliant products, customer claims and corrective actions ............................... 11

Section 4 Good practices .................................................................................................................................. 12

1. Construction and layout of buildings ...................................................................................................... 12

2. Layout of premises and working spaces ............................................................................................... 12

3. Cleaning and disinfecting of premises and equipment .......................................................................... 12

4. Skills and hygiene of staff members ...................................................................................................... 13

5. Pest management .................................................................................................................................. 13

6. General services: air, water and steam ................................................................................................. 13

7. Purchasing management: packaging, inflows, service providers... ....................................................... 14

8. Qualification and maintenance of equipment ........................................................................................ 14

9. Reprocessed/recycled products ............................................................................................................ 15

10. Waste elimination .............................................................................................................................. 15

11. Order taking ....................................................................................................................................... 15

12. Storage .............................................................................................................................................. 15

13. Transport ........................................................................................................................................... 16

14. Product information ............................................................................................................................ 16

15. Prevention of malicious acts .............................................................................................................. 16

Appendix 1- Minimum requirements on selecting, monitoring and evaluating suppliers .................................. 17

Appendix 1.1 (Former) foodstuff gatekeeper ..................................................................................................... 24

Appendix 1.2 Gatekeeper protocol for the purchase of cereals, oilseeds and legumes ................................... 30

Appendix 1.3 Gatekeeper protocol for small volumes ....................................................................................... 32

Appendix 1.4 Gatekeeper protocol for processed feed materials ..................................................................... 33

Appendix 2: Guidelines of the Codex for the application of the HACCP system .............................................. 36

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Section 1 Introduction

1. General information

The certification reference for suppliers (manufacturers, distributors, traders) of animal feed producers was developed to contribute to the health safety of the animal feed supply chain. The main objectives of this reference are: - To protect the health of livestock and the health of humans that consume animals in the form of meat, or animal products in the form of milk, eggs... - To ensure that the feed materials for animal feed meet health safety requirements. To meet this reference, suppliers of feed materials for animal feed must apply hazard analysis principles (HACCP) and good manufacturing practices. They must also prove that checks are carried out at each stage of the supply chain to guarantee the quality and health safety of the feed materials supplied for animal feed.

2. Scope of application

This reference defines the requirements that suppliers of feed materials for animal feed under the meaning of EU regulation 767/2009 must comply with for operations such as agglomeration, cooking, crushing, decortication, dehulling, desiccation, dehydration, extrusion, flaking, …

Operators whose activities are eligible for CSA/GTP certification as well as transport operators eligible for QUALIMAT Transport or equivalent are excluded from the scope of application. This reference also includes all purchasing operations, transport of feed materials for animal feed and distribution to animal feed manufacturers. The exclusion of manufacturing activities presents on the site and covered by the certification scope is not permitted.

3. Terms and Definitions

Acceptance: Control operation of an incoming good to permit its entry on a production site. Batch or lot: An identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together (Regulation 767/2009).

Batch delivered: Quantity of feed delivered at one occasion in one place.

Batch manufactured: Group or set of identifiable feed considered as qualitatively homogenous consisting of a mixture or a set of successive mixtures of the same formula, or mixtures grouped in the same production cycle.

Capability: Capacity or ability to achieve a product conformed to the requirements for this product.

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Calibration: operation that, under specified conditions, establishes a relation between the quantity values

with measurement uncertainties provided by measurement standards and corresponding indications with

associated measurement uncertainties and, then uses this information to establish a relation for obtaining a

measurement result from an indication.

CCP or critical control point: Step at which control can be applied and is essential to prevent or eliminate a

food safety hazard or reduce it to an acceptable level (ISO 22000).

Conformity: Fulfilment of a requirement. (ISO 9001)

Contamination: The undesired introduction of impurities of a chemical or microbiological nature of foreign matter into or onto an incoming or a finished feed during production, sampling, packing or repacking, storage or transport (EFMC guide).

Control measure: Action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level (ISO 22000)

Corrective action: Action to eliminate the cause of a detected nonconformity to prevent recurrence. (ISO 9001)

Critical limit: Criterion which separates acceptability from unacceptability (ISO 22000).

Curative / Corrective maintenance: Maintenance carried out on equipment for its rehabilitation after a breakdown.

Default: Non-fulfilment of a requirement for a specified use or expectation.

Disinfection: Reduction, by means of chemical agents and/or physical methods, of the number of microorganisms in the environment, to a level that does not compromise food safety or suitability.

Distributor: physical holder of feed (excluding retail) performing the following process steps to the exclusion

of any other: procurement, reception, storage - transfer, loading and delivery.

For the purpose of this standard, the terms "feed" will be used for all products falling within its scope (premixes

and all types of feed).

Documented information: information and format to be managed and controlled by an organization (ISO

9001).

Feed business: Any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on his own holding (Regulation 178/2002).

Feed hygiene: Measures and conditions necessary to control hazards and to ensure fitness for animal consumption of a feed, taking into account its intended use (Regulation 183/2005).

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Feed materials: Products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixes (Regulation 767/2009).

Feed Safety : Under article 15, §2 of regulation 178/2002, feed shall be deemed to be unsafe for its intended use if it is considered to:

- have an adverse effect on human or animal health; - make the food derived from food-producing animals unsafe for human consumption.

Hazard: Biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an

adverse health effect (Regulation178/2002).

Hazard Analysis and Critical Control Points (HACCP): A method to identify process steps where a loss or significant deviance from the required product quality and safety could occur if no targeted control is applied. (IFIF guide)

Merchant: an economic operator exclusively carrying out purchases and resale actions in the form of incoming materials or compound feed (without physical possession of incoming materials or feed).

Monitoring: Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended.

Note: For CCP, monitoring should be permanent, that is conducted throughout the process, and related to one or more batches. It can be performed continuously (e.g. automatic registration of sterilization heat treatment) or discontinuous (e.g. control the gas composition of the products packed under modified atmosphere if the step is considered CCP).

For oPRP, monitoring should be regular but is not necessarily permanent.

Note of French authorities DGAL/SDSSA/N2012-8156 du 24 juillet 2012

Nonconformity: Non-fulfilment of a requirement (ISO 9001).

Operational prerequisite program (PRPo): PRP identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards (3.3) to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment (ISO 22000). In this guide, the term oPRP will be replaced by Point of Attention (PA)

Packaging article: Element for containing the feed to provide it an essentially physical protection and bear the information required for its usage. It participates in its preservation, identification and proper use.

Pests: Insects, birds, rodents and other animals including domestic which could directly or indirectly contaminate feed.

Pesticides: Pesticides should be understood broadly: insecticides, herbicides, fungicides, rodenticides, destruction of "Pest".

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Placing on the market: Holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves (Regulation 178/2002).

Planning: Set of actions to implement, including definition of responsibility and deadlines.

Prerequisite program (PRP) or Good Hygiene Practice (GHP): Basic conditions and activities which are necessary to maintain a hygienic environment throughout the food chain (3.2) suitable for the production, handling and provision of safe end products (3.5) and safe food for human consumption (ISO 22000).

Preventive action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation (ISO 9001).

Preventive maintenance: Preliminary maintenance of equipment intended to prevent breakdowns.

Processing aids: Any substance not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfill a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed (Regulation 1831/2003).

Production site: defined geographical site corresponding to an identified legal entity

Recall: Any measure aimed at achieving the return of a dangerous product that has already been supplied or made available to consumers by the producer or distributor (Directive 2001/95).

Recommendation: Material or organizational suggestion that can be considered in a continuous improvement goal.

Record: Document stating results achieved or providing evidence of activities performed (RCNA).

Required ability: Measurement needed by the company to determine if the conformity of products is fulfilled.

Return: Recovery of food by the manufacturer or the distributor, although presenting or not a manufacturing defect.

Risk: Function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard (Regulation 178/2002).

Safe: incoming feed materials are considered to be safe if they do not have adverse effect on human and animal health, and if food derived from food-producing animals are not injurious to human and animal health or unfit for human consumption where the feed is used according to its intended use and in accordance with industrial or feed practices (Regulation (EC) 178/2002, adapted)

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Sanitation: All operations to obtain and maintain adequate hygiene. This includes the operations of disinfection and pest control.

Traceability: Ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution (Regulation 178/2002).

Undesirable substance: Any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production (Directive 2002/32).

Validation: Obtaining evidence that the control measures managed by the HACCP plan and by the operational PRPs are capable of being effective (ISO 22000).

Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

Waste: "Waste is any residue of a production process, processing or use, any substance, material, product, or basically anything that is discarded or that the holder intends to discard. "(Environmental Code, legislative provisions, Article L 541-1).

Zero point: Refers for a storage unit at the time where it was empty and recorded as such.

Section 2 Management Responsibility

1. Commitment and Feed Safety Policy for animal feed

Management:

- prepares a documented policy that explicitly defines its commitment to complying with regulatory requirements in terms of the health safety of the processed materials and compliance with customer requirements;

- sets up documented targets in line with the policy;

- and provides suitable resources to achieve the set targets.

2. Management system for animal feed safety

The site must prepare, document, implement and maintain a management system for animal feed health safety. The system's scope must guarantee that all activities likely to have an impact on health safety are taken into consideration. The animal feed health safety management system must be updated as required (new processed materials, new customers, …). When a Guide to Good Hygiene Practices exists, it must be taken into account in preparing the animal feed health safety management system. In the absence of a GGHP, appendix 1 of the Guide to Good Practice in Animal Feed (GBPNA) may be used as a basis for preparing the animal feed health safety management system.

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3. Responsibility and authority

The responsibility and authority of the employees carrying out the tasks related to animal feed health safety must be documented. The manager responsible for steering the animal feed health safety management system must have the relevant authority to effectively assume this function. All persons with activities related to animal feed health safety must be aware of their impact. They must be qualified and trained, and records of employee skills assessments must be available.

4. Management of emergency situations (alerts / crises):

A documented management procedure for product withdrawals/recalls must be in place, and enable fast stakeholder information (customers, authorities, suppliers...).

The competent authorities, the certification body and OQUALIM must be alerted as soon as possible in the event of serious health safety risks, when the legal limits have been exceeded and when national legislation requires mandatory alert.

The procedure must describe the responsibilities and actions to be taken.

Stakeholder contacts must be listed and kept updated.

In the event of a product recall, it is important to:

- identify the non-compliant batch, including the consequences for other feed materials for animal feed,

- manage returns of feed materials for animal feed,

- and record the destination of all feed materials for animal feed recalled.

The recall procedure must be tested for effectiveness. These tests must be documented and assessed in order to improve the system if required.

5. Management review

A management review must be conducted on an annual basis and must enable a report on the effectiveness of the health safety management system for feed materials destined for animal feed to be produced (report on customer claims, non-compliant products, withdrawals/recalls, results of non-compliant analyses..).

Section 3 Management of animal feed safety

1. General documentary requirements

The documented information must be managed in line with the risk analysis. The records must be:

- stored for a minimum of 2 years, unless there are stricter requirements, such as for traceability items (see paragraph 3),

- stored in such a way as to avoid all information loss (suitable conditions),

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- easily accessible,

- readable.

The site must document:

- the quality policy and related goals.

- its HACCP analysis,

- the procedures and records required by this reference.

2. Regulatory monitoring

The site must show that an organisation in place enables information on regulatory, scientific and technical requirements related to the health safety of feed materials for animal feed.

Organisations (for example, professional organisations) active in the company's sector of activities and the official national sites (for example Légifrance, ANSES...) are relevant monitoring sources.

The communication system in place must allow the concerned responsible persons to be reliably and effectively informed. The actions required for compliance with regulatory changes must be effectively implemented.

3. Identification and Traceability

The site must set up a system of traceability in order to identify the feed materials for animal feed received and the processed/delivered materials. The traceability of the feed materials is ensured as a minimum by the storage of the following data:

- supplier names and addresses,

- the type and quantity of feed materials entering, delivery date and/or batch number received, means of transport and the unique transporter identification reference. The traceability of the feed materials for animal feed is ensured as a minimum by the storage of the following data:

- the type of materials (including the feed materials used) and their quantity,

- batch identification,

- customer names and addresses. The traceability must be ensured up to the time when the responsibility for the processed materials is transferred to the buyer (including during storage or transport). The documents must be kept for 5 years.

4. Hazard analysis according to the 7 principles of the HACCP method

It is recommended to implement the preliminary steps (Appendix Codex Alimentarius Guidelines for the application of the HACCP method) when applying the 7 principles of the HACCP method.

4.1 Principle 1:

The HACCP team must identify and document all relevant hazards (chemical, physical, microbiological) as well as the acceptable levels defined in the regulations or customer requirements.

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A hazard analysis must be deployed for each feed material and at each stage of production of the processed materials according to flow diagrams.

The hazards are assessed according to two criteria: their probability / frequency of appearance in the material under consideration and their seriousness in terms of effect on the animal and/or on consumers. The method used to determine risk levels must be clearly described, objective, repeatable and understood by the entire team.

Documented management measures must be deployed to manage the potential hazards. These measures must enable new hazards to be prevented or the presence of existing hazards to be detected/eliminated.

4.2 Principle 2

The essential control measures to detect and eliminate hazards are considered as critical control points (CCP) or attention points (AP).

For hazards assessed as presenting a significant level of risk, specific control measures are determined; these measures are classified as CCP or Attention Points, with CCPs being defined as steps in the process and Attention Points being defined as "Essential Good Practices".

A decision tree may be used to help with this classification.

4.3 Principle 3 of the Codex Alimentarius

Critical limits must be defined and validated as effective to control the significant hazards identified related to the CCPs.

The proof of effectiveness of the critical limit must be available.

Each specific control measure (CCP / Attention Point) or combination of control measures is validated as being effective to maintain the hazard at an acceptable level. This validation involves determining critical limits for the CCPs and monitoring limits for the Attention Points (the deviation of a CCP systematically impacts processed materials whereas the impact is not systematic for Attention Points).

The validation proofs are documented.

4.4 Principle 4 of the Codex Alimentarius

The CCP/Attention Points must be monitored in order to guarantee the control of the significant hazards identified. The monitoring results must be documented.

All persons conducting monitoring of CCPs or Attention Points must be qualified and trained.

4.5 Principle 5 of the Codex Alimentarius

Corrections must be applied when the critical limits have been exceeded; these must be documented.

For each CCP / Attention Point, monitoring instructions are formalised and diffused to the employees responsible for applying them. Corrections to be made in the event of deviations compared to the critical limits or monitoring limits are formalised in these instructions. The instructions provide for the processing of potentially hazardous processed materials and the return to control of operations.

4.6 Principle 6 of the Codex Alimentarius

A full HACCP review must be conducted at least once a year. It must be documented and indicate the review's conclusions on the system's effectiveness, and if required, the actions to be taken to improve it.

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The system must be immediately updated when a modification may impact the health compliance of the processed materials.

4.7 Principle 7 of the Codex Alimentarius

A documentary system concerning all procedures and records applied in principles 1 to 6 must be implemented and kept updated.

5. Verification (internal audits, analysis plans)

5.1 Internal audits

The site must define an internal audit programme to verify the effectiveness of the animal feed safety management system. The scope of the audit must include the requirements of this reference, control of the HACCP plan, compliance of the application of internal procedures, compliance with legislation on safety and quality of processed materials and customer satisfaction. All activities must be audited at least once a year.

The internal auditors must be qualified and trained in audit techniques and have the technical skills for the audited processes, and as far as possible, be independent from the audited activities.

Following reported non-compliance, action plans must be formalised, and their effectiveness validated by a responsible person.

Internal audits may be conducted by external organisations mandated by the supplier.

5.2 Analysis plan

A minimum analysis plan must be set up to analyse the feed materials and processed materials. The frequency of analyses must take into account the volumes and identified risks. The analyses must take into account chemical hazards (such as dioxins, heavy metals and pesticide residues), biological hazards (mycotoxins…), physical hazards and the intrinsic quality of the processed materials (label value).

For each health contaminant identified by the operator, if frequency (F) x severity (G) is higher than or equal to 6, with each criterion being scored from 1 to 4, the following formula must be used to calculate the minimum number of analyses to be conducted: *

Number of analyses =√𝑉𝑜𝑙𝑢𝑚𝑒 𝑥 𝑆𝑒𝑣𝑒𝑟𝑖𝑡𝑦 𝑥 𝐹𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦

300

The volume is an annual volume in tons.

This formula must be applied for each contaminant/product couple. The term "product" may bring together several species if the risk analyses are identical. The result must be rounded up to the nearest whole number.

The analysis results must be documented, based on current regulations and interpreted by a competent person. Action plans must be undertaken and documented in the event of non-compliant results.

6. Management of non-compliant products, customer claims and corrective actions

A management procedure for non-compliant products must be documented. This procedure must include:

- the identification of the concerned batches,

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- the documentation to manage and record the non-compliant feed materials for animal feed,

- the assessment of the reason for non-compliance,

- the isolation of the concerned batches,

- corrective actions to avoid the repetition of the non-compliance,

- and the definition of the responsibility for management of non-compliant feed materials for animal feed.

All management of non-compliant feed materials for animal feed must be documented.

The non-compliant feed materials for animal feed may be redirected in several ways: destruction, processing/transformation, customer acceptance with written proof, reclassification (if they meet the specifications for other feed materials for animal feed).

NB: dilution is not permitted.

Following reprocessing of non-compliant feed materials for animal feed, the risk must be reassessed in order to guarantee batch compliance; this must be documented.

Returns that are not approved in the HACCP analysis must be considered as waste and be eliminated.

A management and processing procedure for customer claims must be documented. This procedure must include the recording of the claim reason, the feed material for animal feed concerned, the customer name, the analysis of the cause, the actions taken to manage the claim, correspondence with the customer and the definition of the responsibility for the management of claims.

Corrective actions must be taken considering the severity and frequency of non-compliance and claims. The effectiveness of the undertaken actions must be verified. All of the steps in the management of corrective actions must be documented.

Section 4 Good practices

1. Construction and layout of buildings

The site must identify all surrounding activities that may represent a source of contamination for the feed materials for animal feed.

Installations (including pipes, gutters and drains) and equipment (including equipment entering into contact with the feed materials for animal feed) must be designed and maintained to avoid them being a source of contamination for the stored or processed materials.

2. Layout of premises and working spaces

The site must organise traffic flows to avoid any contamination of feed materials for animal feed. Specific vigilance must be taken when the manufacturing process includes a sanitising heat treatment step. Measures must be implemented to avoid recontaminating feed materials for animal feed with pathogenic agents.

3. Cleaning and disinfecting of premises and equipment

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A cleaning program must be defined and documented. It must specify the areas, equipment, cleaning methods, products used and the cleaning frequency. The chemical products used must be fitted for purpose, used according to manufacturer recommendations and stored separately. The effectiveness of the implementation of the cleaning and disinfecting program must be monitored and

recorded.

4. Skills and hygiene of staff members

The employees involved in manufacturing must be trained in good hygiene practices and the HACCP principles. The training content must be adapted to the position (more in-depth for workers in contact with feed materials for animal feed). The effectiveness of the training must be verified. The proof of training completion must be available.

Protective clothing must be worn and suited to the identified contamination risks. Clothes must be kept clean.

Hygiene rules must be communicated to all employees and visitors (no smoking, eating or drinking outside of the authorised areas, …).

5. Pest management

The site must implement a pest management plan (all categories of animals: birds, rodents, insects, reptiles) to protect the feed materials and processed materials from potential contamination. The following data must be documented:

- the substances used, including the safety data sheets,

- the plan indicating the location of bait and the bait used,

- the frequency of surveys,

- the results of bait surveys,

- and the corrective measures implemented (in the event of infestations, immediate actions must be taken).

The bait or products used must not represent a source of contamination.

The employees implementing the pest management plan must be qualified / trained and proof of qualification must be available.

Access points must be kept closed if possible. Buildings must be maintained to avoid becoming breeding locations for pests.

6. General services: air, water and steam

When air, water or steam comes into contact with feed materials for animal feed (drying, transport, material cooling), the site must define the risks of contamination and apply suitable control measures. The analysis results of water used for manufacturing or cleaning must be available. These may be conducted by the site or transmitted by the water supplier.

When additives (such as water softeners, anti corrosion agents, etc) are added to the water in liquid or steam form, the doses must be recorded.

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Wastewater and other substances recovered from wastewater systems must not be incorporated into the feed materials for animal feed.

The non-drinkable water circuit must not be linked to the drinking water circuit or enable any backflow.

7. Purchasing management: packaging, inflows, service providers...

Suppliers of feed materials for animal feed must procure their supplies from suppliers certified according to a recognised system (see Appendix 1 of the RCF). When the site procures feed materials for animal feed from a trader, the trader must be certified according to a recognised scheme (see Appendix 1 of the RCF).

Suppliers of feed materials and service providers (notably transport, storage and handling, packaging, analysis laboratories …) must be selected and assessed each year on their ability to comply with contractual requirements. This assessment must be documented. Their respective performance must also be assessed and documented. The technical/contractual requirements as well as the specifications of all feed materials must be formalised in writing.

8. Qualification and maintenance of equipment

The criteria of the hygienic design of equipment must be considered at the time of purchase. New equipment with an impact on the health quality of feed materials for animal feed must be qualified to guarantee its effectiveness. Qualification documents must be recorded. A preventive maintenance plan must be set up for all critical equipment designed for manufacturing safe feed materials for animal feed. The interventions must be recorded.

Corrective maintenance interventions must be controlled to avoid contamination of feed materials for animal feed. The product must be protected or removed during the intervention and the area cleaned before production restarts. Curative maintenance must be recorded.

Lubricants or hydraulic oils suitable for incidental food contact must be used on the equipment parts in contact or close to feed materials for animal feed.

Metrology of measurement, control and monitoring equipment The company must determine and identify the measurement, control and monitoring equipment to obtain or verify the compliance or safety of the feed materials for animal feed. All equipment is identified individually and must be verified on an annual basis. The verification results must be documented. Verification acceptance criteria must be defined.

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When a defect is observed on equipment, the site must study the potential impact on the feed materials for animal feed and, if applicable, undertake corrective actions on the feed materials for animal feed and the equipment.

9. Reprocessed/recycled products

The company must: - Identify the feed materials for animal feed to be recycled. - Define, formalise and assess the recycling modalities taking into account the feed material for animal feed to determine the incorporation rates and modalities during recycling. - Record all recycling operations and store these records according to current legalisation in order to allow traceability.

10. Waste elimination

The company must: - define the modalities for the classification, storage, recovery or destruction of the waste depending on the type of product to be eliminated: - NHW: Non Hazardous Waste - HW: Hazardous Waste - Select the companies specialising in the take-back, recovery and elimination of the different waste categories.

- Record and store the documents listing the products and packaging sent to recycling or destruction.

11. Order taking

The feed materials for animal feed must be sold in accordance with the contractual specifications and modalities defined and made available to all potential purchasers. The contract and/or specifications must stipulate the specific requirements/conditions of transport, storage or use required to maintain the characteristics of the feed materials for animal feed. The specifications for the feed materials for animal feed must be formally accepted by the purchaser and manufacturer and be confirmed in the contract. The contracts must clearly stipulate the name and specification of the feed material for animal feed, the quantity and period of collection/delivery. The company must set up a system for verifying and validating the orders made by its customers. Orders made must be recorded and include the feed materials for animal feed and quantities ordered. The manufacturer must deliver a feed material for animal feed that complies with the specifications validated with the customer.

12. Storage

The storage of feed materials for animal feed and potentially hazardous feed materials for animal feed must be physically separated. All feed materials for animal feed must be identified.

A physical control of inventories must be set up and documented. Inventories must be managed according to the First In First Out rule.

Feed materials for animal feed must be protected during storage (closed bag...).

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When the storage of feed materials or processed materials is remote (externalised or not), the same rules for good storage practices apply. The external storage service provider must be audited at least once a year by the order giver or certified according to a recognised scheme.

13. Transport

The company must: - use suitable transport means and conditions for the type of transport (rail, water, road) to preserve the integrity of the feed materials for animal feed: - ensure that the vehicles, conveyors, containers and all protection (eg covers or sheets) are correctly maintained, clean and in a state consistent with the requirements indicated in the concerned specifications. - verify the compatibility of the feed materials for animal feed transported to avoid all cross-contamination risks. - in the event of bulk transport, in compliance with safety rules, set up suitable provisions to determine, assess previous loads, cleaning and disinfecting operations conducted according to IDTF rules and QUALIMAT Transport specifications. - record the loading and delivery information including the traceability and identification of the means of transport (compartment number, trailer/wagon, hold...).

In the event of an unsatisfactory control of the means of transport, the purchaser must be informed in writing. Written confirmation from the purchaser must be received before the load is validated. The exchanges must be stored.

Controls of all feed materials for animal feed received and shipped must be conducted. These must include a visual check (for example, colour, shape, smell, presence of insects, dejections, mould, other foreign bodies) and a check of compliance with specifications.

A sample of each feed material and processed material must be kept in a closed, labelled container.

The sampling techniques and frequency must be suitable to guarantee the representativeness of all feed materials for animal feed delivered. The sampling plan must be suited to the volume and type of feed materials and processed materials concerned.

Samples must be kept for at least the lifetime of the guarantee of the feed materials for animal feed and by default for at least 6 months, unless risk assessment studies show that shorter periods are sufficient or that longer periods are required.

14. Product information

Feed materials for animal feed sold in bulk or bags must be accompanied by delivery documents/labels indicating all required legal information according to the labelling rules for the countries of manufacturing and sale.

15. Prevention of malicious acts

The company must:

- Assess the hazard level for the feed materials for animal feed for potential acts of sabotage, vandalism or

terrorism.

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Appendix 1- Minimum requirements on selecting, monitoring and evaluating suppliers

I- OBJECTIVE

Set the base of common requirements to be met by suppliers of companies’ candidates to the RCF certification.

II- DEFINITION Merchant of feed materials: an economic operator exclusively carrying out purchases and resale actions of feed materials (without physical possession of feed materials).

III- SCOPE

Purchases concerned by these minimum requirements to apply for RCF are the following: - Supply of feed materials, - Transport service.

CASE OF PRIMARY AGRICULTURAL PRODUCTS: Primary agricultural products (tubers, roots, grains, oilseeds, etc.), which are provided directly by the farmer are not required to obtain feed or food safety certification. The producer of primary agricultural products must comply with Regulation (EC) No 183/2005. It must be registered as an animal nutrition operator by the competent authorities. Possible impacts of primary agricultural products on the safety of animal feed should be considered in the HACCP study of the company certified by OQUALIM (eg. concentration of undesirable substances in feed materials). When the delivery of primary agricultural products is made by farmers, manufacturers of feed will define the requirements, for example regarding the cleanliness of the transport vehicle, and verify that these requirements are met.

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IV- Referencing criteria by type of product or service

IV-1 Feed materials Suppliers of feed materials must implement a HACCP analysis of all their feed materials based on the GBPH, if possible. If there is no GBPH, the Appendix 1 could serve as a basis to set the HACCP of feed materials.

The specific control measures implemented by the supplier of feed materials must be consistent with the results of the HACCP feed materials analysis.

The "RCF" certified company must ensure that the supplier is certified according to a recognized certification. The supplier certification must cover the feed material concerned. The list of recognized certifications is present "in Table 3 / online on the site: www.oqualim.fr".

The referencing of the supplier of feed materials must respect the following flowchart:

*: Irregular or occasional suppliers of small quantities (2 tons / month or 30 tons / year maximum) or referencing of new suppliers whose main activity is not feed

**: The RCF-certified company carries out a hazard analysis of the 'feed material' or additive. This analysis is based on the HACCP method. The company must have documentation describing the supplier's manufacturing processes and the product it purchases (eg production diagrams, on-site evaluation reports, control limits, monitoring program and frequency of monitoring activities, technical sheets, certificates of analysis, etc.). The company puts in place a control plan for the feed material or additive based on the result of the hazard analysis it has carried out. The RCF certified company informs its Certification Body and OQUALIM of the use of this type of supplier, of the hazard analysis carried out and of the control plan implemented. During the audit, the auditor will verify the respect of this analysis, the associated documents and the relevance of the whole in case of purchase of this type.

Table 3. List of certifications compatible with OQUALIM for additives and feed materials suppliers for animal feed

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Certification to ensure compliance with criteria

The additives and or the feed materials must be within the scope covered by the certification.

CSA-GTP (collection, storage, placing on the market and transportation of cereals, oilseeds and protein crops).

EFISC GTP for feed materials from vegetable oils and protein meal, starch industries and collection, storage trading and transport of grains, oil seeds and coproducts.

Fami-QS production and trading of feed additives

FCA - ‘BC-02-GP : Production of Feed Materials’‘, FCA BC-03-GH : Trade in Feed Materials’‘, FCA BC-02 –TP Production of additives, FCA BC-03-TH Trade in additives, FCA BC-02 VWH and GPVW “Production of ‘by-products for reprocessing”.

FEMAS for “ Production of Feed Materials” mentioned on the certificate.

GMP+ FSA - B2 “Production of Feed Materials’‘- GMP+ B1 – “production of feed materials”- GMP+ B1 – “trade in feed materials” - GMP+ B3 – “trade in feed materials” - GMP+ B1 – “production of additives”- GMP+ B1 – “trade in additives” - GMP+ B2 “Production of additives” - GMP+ B3 – “trade in additives”. The supplier must always communicate by writing the feed status (certified or not, either in the sales contract, or the confirmation order, the label, or any other accompanying document, according to one of the formulas defined by GMP+)

QS-certified producers of feed materials, QS-certified producers of additives, QS-certified traders of additives, QS-certified traders of feed materials. When ordering, it will be clearly specified that the ordered animal feed must fall within the scope of the QS certificate.

RCNA “Distribution or Trade in Feed Materials”, “Distribution or Trade in additives”, “Compound feed production” for laminated, extruded, flaked feed materials.

RCF: Standard for suppliers (OQUALIM).

UFAS “Merchants”

Requirements for suppliers of processing aids

Purchasers of chemical products must expressly state that the products purchased will be used in the production of feed as processing aids when ordering.

Manufacturers using processing aids must carry out an assessment in HACCP of the risks of residues of these auxiliaries or their derivatives when their residual presence in the feed is technically unavoidable. They must offer guarantees that the use of processing aids does not pose a risk to the feed safety. For this purpose, the manufacturer will request the following information from its supplier to carry out a correct risk assessment:

- impurities present in the processing aids, and obligatorily potential contaminants and undesirable substances for animal feed,

- interactions between substances,

- substances which may form in relation to the manufacturing process,

- the chemical reactivity of the processing aid,

- the residue content after reaction.

The manufacturer must ensure from its supplier that:

- producers and distributors guarantee the traceability of processing aids,

- producers are aware of the provenance, processes and applications of their products,

- distributors are aware of the origin and applications of their products,

- producers shall only place on the market processing aids with specifications on the basis of a hazard analysis.

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The list of CSA-GTP certified suppliers is available at: https://charte.incograin.com

The list of EFISC GTP certified suppliers and the certification scope is available on the website www.efisc-gtp.eu.

The list of Fami-QS certified suppliers of additives is available at: www.fami-qs.org

The list of FCA certified suppliers and the certification scope is available on the website: www.ovocom.be

The list of GMP+ certified suppliers and the certification scope is available on the website: www.gmpplus.org

The list of QS certified suppliers and the certification scope is available on the website: www.q-s.de

The list of UFAS or FEMAS certified suppliers and the certification scope is available on the website : www.aictradeassurance.org.uk

IV-2. Transport Definitions:

Transport operator: transport professional who is entrusted with the transport of "products" intended for feed. This transport operator may be either a public carrier or a commission agent.

Own-account transport: manufacturer with its own fleet of vehicles.

All bulk transport operators must have a valid QUALIMAT TRANSPORT or equivalent certification.

Any manufacturer that carries own-account bulk transportation meets the transportation requirements set out in the RCF.

The list of certified QUALIMAT TRANSPORT operators as well as the list of certifications equivalent to QUALIMAT TRANSPORT are available on the website www.qualimat.org

The requirements of the manufacturers will be formalized in the order review and contract review.

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V- MINIMUM CRITERIA OF REFERENCING TO IMPLEMENT GATEKEEPER PROTOCOLS* A gatekeeper company is a certified company undertaking purchases to a non-certified company.

Responsibilities and requirements

The gatekeeping company is responsible for:

• Ensuring that the feed material entering in the animal food chain is sure.

• Respecting the established and mandatory protocols. In case of nonconformity, the certification of

the company is affected.

The company must: - establish a clear and non-ambiguous contract with its supplier regarding to:

• the respect of all the applicable conditions mentioned in the protocols

• the responsibilities (“who does what”)

• forwarding of relevant information, including requested content in the protocols

- follow-up the implementation of a management system. The results of this monitoring shall be

evaluated and if necessary, control measures must be taken,

- hold data and relevant elements, related to the application of the protocols.

Minimum criteria for referencing of all suppliers, in the case of the gatekeeper protocols, are detailed in the table 1

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Table 1 - Referencing Criteria

Referencing criteria (excluding primary production)

The European supplier must be authorized or registered as an operator of animal nutrition by the competent authorities within the meaning of Regulation (EC) No 183/2005. French suppliers will comply to the amended “arrêté du 28 février 2000” if applicable. http://agriculture.gouv.fr/alimentation-animale-0)

The incoming materials are authorized and labelled in accordance with the regulations in force (catalog of feed materials UE 68/2013, Regulation (CE) n°1831/2003 on additives for use in animal nutrition, Regulation (CE) n°767/2009 on the placing on the market and use of feed.

For products of animal origin, the supplier is authorized under Regulation (EC) No 1069/2009. An accompanying commercial document is provided characterizing the product of animal origin.

The supplier has implemented an explicit HACCP risk analysis for incoming materials used for animal nutrition feed.

The supplier sets up, implement and maintain formalized procedures based on the 7 HACCP principles

based on the 12 steps of the Codex Alimentarius. If a good hygiene practice guide exists for its activity, it

issued as a support by the supplier.

The supplier has set up a traceability system compliant to Regulation (EC) No 178/2002

The supplier has defined the management of non-conform products and the procedures of withdrawal / recall falling under Regulation (EC) No 178/2002

The supplier undertakes to introduce appropriate control measures in accordance with its HACCP analysis in order to comply with the regulations on “undesirable substances” (Directive 2002/32/EC), microbiology (zoonosis directives), "pesticides" residues, etc... ) linked to its activity and its outgoing feed.

When the manufacturer has specific requirements for the control of a hazard identified in his hazard analysis, he must oblige his supplier to respect them.

The regulatory requirements in force in the European Union and also applicable to suppliers in third countries wishing to supply the European market must be applied by them.

'In the case of substances imported into Europe from Third Countries and subject to the application of Article 24 of Regulation n° 183/2005 (EC), the supplier must obtain the import. "

Distributors, merchants must source from suppliers (except primary production) complying with the requirements set out in the table above. Suppliers located in third countries and wishing to supply the European market must apply the regulatory requirements in force in the EU.

Application of the HACCP principles

The gatekeeper company must perform a hazard analysis, defined the measured to be implemented and controlled.

Data for hazard analysis

All information on the product, manufacturing processes and environment, influencing the health safety must be gathered.

Necessary data: - product specification

- manufacturing process (existing production diagram?)

- the incoming materials and auxiliary aids used

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- HACCP study: Hazard identification linked to feed materials and production, type of control

measures implemented, which type of monitoring is done?

- Which guarantees are provided by the producer? Standard measures put in place, at least the

HACCP?

- Legal registration requirement

- Feed safety data sheets,…

Based on this evaluation, the gatekeeping company must define and implement the necessary measures in order to ensure the feed health safety.

A supplier audit allows to obtain the additional information, confirm all provided elements, and verified the level and effectiveness of the health safety on-site.

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Appendix 1.1 (Former) foodstuff gatekeeper

1. Introduction

This protocol is meant to purchase (former) foodstuffs via a gatekeeper system for use in feed, for purchases to non-certified company.

This protocol is not applicable to food grade dairy feed materials.

This protocol is not applicable when the (former) foodstuff demonstrably originates from a company already certified according to a recognized feed safety assurance scheme. This company must bring the production of the (former) foodstuff under the scope of his feed safety certificate in case he wants to sell the (former) foodstuff to other feed companies.

Intention should be to process the (former) foodstuffs into a feed product by the gatekeeper. Therefore, the scope ‘Production’ is necessary. Exception: the product may only be sold one step further down the chain, under the scope ‘Trade’, to a company with a production scope. Relevant information must be provided.

Excluded from the scope

• By-products originating from the food industry (e.g. beet pulp, brewers’ grain, etc) and manufactured for

animal feed

• Feed materials for foodstuff

• Feed additives

• Prohibited products

2. Definitions

Term Description

Foodstuff (intended for use as feed)

Any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Food includes drink, chewing gum, as well as any substance including water, intentionally added to food during production, preparation or treatment (Regulation (EC) No. 178/2002).

Former foodstuff (intended for use as feed)

‘Former foodstuffs’, means foodstuffs, other than catering reflux, which were manufactured for human consumption in full compliance with the EU food law but which are no longer intended for human consumption for practical or logical reasons or due to problems of manufacturing or packaging defects or other defects and which do not present any health risk when used as feed. (Commission Regulation (EU) No 68/2013)

Prohibited products Products which are neither intended nor suitable for human consumption due to risk for human health and/or products of which the circulation and use in animal feed is prohibited.

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3. Requirements for the gatekeeper

3.1 Supplier evaluation

To reference the supplier, the gatekeeper company conducts a desk study of the supplier to ensure specific measures for the (former) foodstuff on the basis of a HACCP study.

The risk assessment is carried out per (group of) (former) foodstuff per supplying food company, in consultation with the buying animal feed company.

The risk assessment must encompass all operations and activities, from original production of the (former) foodstuff up to delivery to the participant purchasing the (former) foodstuff and must result in addressing and controlling all hazards related to the (former) foodstuffs.

Results of this risk assessment must be laid down in a Feed Safety Data Sheet (FSDS), (as given in alinea 4 of this sheet).

The FSDS for the (former) foodstuff need to provide necessary information to evaluate potential risks and to define the appropriate use in feed. The FSDS provides a description and specifications in feed, data for identification and production, information from the HACCP analysis, ingredients used and chemical composition, storage and transport instructions, control,…).

The FSDS is updated when products or manufacturing processes are modified and at least once each 3 year.

3.2 Supplier audit

Each year, the gatekeeper performs an audit at the food company. When food supplier company is certified for BRC, IFS, ISO/FSSC 22000, 1 audit / 2 year is sufficient.

In any case, the gatekeeper performs an audit prior to any initial delivery of (former) foodstuffs and in case of significant changes in the product and/or production process.

Internal auditors must be qualified to perform this task and must have an independent position in relation to the supplier and to commercial activities of the feed company.

The gatekeeper who wishes to conduct the supplier audit but does not have qualified supplier auditors, may delegate the conduction of these audits.

Monitoring in accordance with HACCP principles as laid down in the core standard of the scheme.

Witness audit (third party audit)

The gatekeeper gives full cooperation to the verification of the supplier audit by his certification body.

The auditor of the certification body is independent with respect to the audited supplier.

No witness audit will be performed during the initial supplier audit by the gatekeeper at the supplier.

Minimum number of witness audits per year depends on number of suppliers that are assured by the gatekeeper and is calculated as follows:

• 1-10 suppliers = 1 witness audit / 3 years • 11- 50 suppliers = 1 witness audit /2 years

• 51-100 suppliers = 1 witness audits / year

• Over 100 suppliers = 2 witness audits / year

The auditor of the certification body selects, risk-based and in consultation with the gatekeeper, which suppliers are visited. Logistical reasons should be an important selection criterion. Preferably, the witness audit will be carried out during a certification audit.

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No witness audit is required in case the supplier audit is conducted by a qualified auditor of a certification body.

3.3 Records

The gatekeeper creates a feed safety data sheet (FSDS), or an equivalent document, in cooperation with the supplier per batch of product and per supplier. See alinea 4 for an example of an FSDS. The commercial documents should refer to the FSDS or an equivalent document.

A written agreement with the food company about the rights and obligations for guaranteeing the requirements as specified in this protocol. The gatekeeper purchasing (former) foodstuff that is not yet suitable as feed material must process the product into a feed material first. A validated treatment or cleaning must be performed to remove physical contaminants (e.g. glass, plastic, metal) before the (former) foodstuffs can become intended for feed. The treatment or cleaning must be in accordance with scheme requirements.

Resell of (former) foodstuff that has to receive a validated treatment or cleaning to remove physical contaminants (e.g. glass, plastic, metal) before becoming suitable for feed is possible under the next conditions:

- Under the scope “Trade” - To a company with a Production scope for further processing into a feed material; - There is a clear agreement between this ‘gatekeeper’ and the final producer; this agreement gives

guarantees about the responsibilities for buying according to the requirement of this protocol, and about correct processing into a feed material;

- All relevant information about the necessary processing of the (former) foodstuff into a feed material must be provided (=the former foodstuff is accompanied with the FSDS and all the necessary information in accordance with the requirements as laid down in Annex VIII of Regulation (EC) No. 767/2009.)

- The processor of the (former) foodstuff must be involved in the supplier audit of the food company concerned.

4. Model of Feed Safety Data Sheet (FSDS)

The Feed Safety Data Sheet, or equivalent document, which the participant and the non- certified food company or company that wants to dispose of (former) foodstuff must fill out, includes at least the topics mentioned in the FSDS below. Participants can use this FSDS as an example to draw their own FSDS.

FSDS

Feed Safety Data Sheet

0.1 Product

0.2 Status

0.3 Version

0.4 Version date

1. Responsibility for the Feed Safety Data Sheet

1.1 Name of company producing (former) foodstuff(+)

Name

Contact Address:

Town:

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Telephone

Fax

E-mail

Website

1.2 Approved by

(Name and position of the competent official representative of the company)

1.3 Name of commercializing company (trade – if applicable)

Name

Contact Address:

Town:

Telephone

Fax

E-mail

Website

1.4 Approved by

(competent official company)

1.5 Name of the processing company (manufacturing compound feed or premixes)

Name

Contact Address:

Town:

Telephone

Fax

E-mail

Website

1.6 Approved by

(competent official company)

2. Identification of the product

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2.1. Product name

2.2. Trade name

2.3. Article code of the company

2.4. Permit number (if applicable)

2.5. Product description

2.6. Origin (produced by)

2.7. Supplied by (if different from 1.3)

2.8. Production process

2.9. Ingredients and auxiliary substances used (including feed additives and processing aids)

2.10. Logistical process (transport, (interim) storage, packaging)

2.11. Storage life

2.12 Indicative analysis Parameter Unit Average Min. Max.

3. Standards / requirements

3.1 Relevant legislation and other requirements

3.2 Relevant product standards (chemical, physical, microbiological)

Parameter Unit Statutory Contractual Internal

3.3 Intended use + reason for destination feed

3.4 Processing of the product (indicate whether the (former) foodstuff needs further processing or has been processed into feed material)

3.5 Processing steps and instructions for processing

3.6 Storage and retention requirements

3.7 Transport requirements

4. Labelling

5. HACCP

5.1 Hazard 5.2. Risk assessment 5.3. Control measures

5.4. Reason

Category (C, M, P)

Likely Severity Risk

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ccurence

6. Monitoring

6.1 Parameter 6.2 Sampling moment / point 6.3. Frequency of analysis

7. Communication in case of non-conformities

In case the batch does not correspond with the FSDS or the suspicion exist that the health of animals or the food/feed safety is in danger, this must be actively reported to the gatekeeper.

8. Remarks

9. Signatures

…………………………………..

DD / MM / YY

Company (Purchaser, gatekepeer)

…………………………………..

DD/ MM / YY

Non-certified company (Supplier)

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Appendix 1.2 Gatekeeper protocol for the purchase of cereals, oilseeds and legumes

1. Introduction

This protocol applies to

a) Purchase of cereals, (oil-)seeds and legumes in unprocessed form from a company non certified by

a scheme recognized by OQUALIM, from all countries with the exception of Germany, Austria,

Belgium, Canada, Denmark, France, United Kingdom, Greece, Ireland, Italy, Luxembourg, the

Netherlands where this gatekeeper protocol does not apply. b) Purchase of intervention grain.

Each year, OQUALIM evaluates together with interested parties, countries concerned by this gatekeeper protocol.

RCF certified companies, purchasing grains, seeds and legumes from one of the above indicated territories origins, must apply such protocol.

Primary products directly purchased from primary producers are not affected.

These feed materials can be transported by waterway (sea vessel, lighter or coaster), by rail or by road.

The company, applying this gatekeeper protocol must notify OQUALIM and the certification body beforehand. To this end, it is sufficient to send an email to [email protected] and to the certification body, mentioning the feed material and its origin.

2. Monitoring and sampling

2.1 Sampling

Any delivery of the above mentioned feed materials, must be sampled and analyzed. The frequency of analysis is different depending on the transport means.

Transport Sampling Inspection

Ship 1 per hold Each sample

Lighter/coaster: 1 per lighter/coaster Each sample

Train 1 per train Each sample

Vehicle. 1 per vehicle Every 20th sample

If one can demonstrate that multiple deliveries (or shipments) are part of the same batch, it is sufficient to analyze the batch upon the first delivery, provided it can be proven in writing that the sampling and the analysis are representative for this batch.

2.2 Monitoring

The RCF certified company carries out its own hazard analysis for the complete preliminary process (cultivation, harvest, collection, transport). On the basis of this hazard analysis and the guarantees which are to be provided by the previous links in the chain, the RCF certified company makes a selection of the supplier and draws up a monitoring program which at least complies with the requirements of this protocol. Special attention should be paid to new origins or suppliers. Mycotoxin levels can vary greatly from season to season and should be given special attention especially at the beginning of each season.

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The analysis of the parameters indicated below must be performed, mandatorily, for each relevant feed material.

Parameter Remarks/explanation

Crop protection agents and pesticides

See the minimum list of pesticide molecules defined for OQUALIM approved laboratories

Heavy metals (Arsenic, Lead, Mercury, Cadmium)

According to risk assessment

In the event of artificial direct drying using another fuel than gas: - Dioxins - Sum of dioxins and

dioxin-like PCBs - Non-dioxin like

PCBs - PAHs

In case the gatekeeper has a written statement from the drying company that proves

- natural gas is used, or

- indirect drying is applied,

the monitoring can be reduced (in accordance with HACCP / core standard).

The whole batch must be kept segregated from the other batches, unless these are tested and approved.

Salmonella According to risk assesment

HCN Linseed

Free gossypol Cotton seed

Rye ergot Wheat, rye and triticale

Mycotoxins

-Aflatoxin B1

-Deoxynivalenol (DON)

-Zearalenon (ZEA)

-Ochratoxin A (OTA)

At least applicable for maize,

At least applicable for all cereals,

At least applicable for all cereals and soya beans

At least applicable for all cereals,

2.3 Notification of analysis results

OQUALIM shall be notified of all deliveries falling under this protocol, along with the analysis results.

If a batch is supplied to multiple companies, it is sufficient for one company to communicate the analysis results. In this case, all companies having received their supplies on the basis of this protocol, must be indicated. There is no obligation to block the feed materials pending the analysis results.

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Appendix 1.3 Gatekeeper protocol for small volumes

1. Introduction

This gatekeeper protocol defines the requirements for purchasing from non-certified companies in a way that allows small-volume suppliers to be controlled.

2. Definition Small volumes suppliers: Irregular or occasional suppliers of small quantities for feed production (2 tons / month or 30 tons / year maximum) or referencing of new suppliers whose main activity is not feed.

3. Requirements

The RCF-certified company carries out a hazard analysis of the 'feed material' or additive.

This analysis is based on the HACCP method. The company must have documentation describing the supplier's manufacturing processes and the product it purchases (eg production diagrams, on-site evaluation reports, control limits, monitoring program and frequency of monitoring activities, technical sheets, certificates of analysis, etc.). The company puts in place a control plan for the feed materials or additives based on the result of the hazard analysis it has carried out.

The RCF certified company informs its Certification Body and OQUALIM of the use of this type of supplier, of the hazard analysis carried out and of the control plan put in place.

During the audit, the auditor will verify the respect of this analysis, the associated documents and the relevance of the whole in case of purchase of this type.

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Appendix 1.4 Gatekeeper protocol for processed feed materials

1. Scope

This protocol defines the requirements for purchasing processed feed materials from suppliers not certified by a scheme recognized by OQUALIM.

This protocol is not applicable for feed materials for which there is an existing protocol ((former)foodstuffs and small volumes).

For (former) foodstuff gatekeeper protocol see appendix 1.1,

For small volumes gatekeeper protocol see appendix 1.3.

The application of this protocol is submitted to restrictions depending on the origin of the supplying source.

Each year, OQUALIM will evaluates together with interested parties, countries concerned by this protocol and the list of processed feed materials concerned. Spain, France, Italy and Poland will be the next countries to be evaluated in 2020.

This protocol is currently being harmonized with the other schemes involved in feed safety. It may be subject to changes during the year.

2. Definitions

Unprocessed feed material: any type of feed material in which the original state i.e physical, chemical or nutritional has not been altered. An exception is made for processes ensuring a stable storage for feed materials. When such a process is performed, the feed material is still considered as unprocessed (e.g Drying, chilling, cleaning/sieving, packaging).

Processed feed material: Any type of feed material in which the original state i.e physical, chemical or nutritional has been altered. (e.g: Crushing/pressing, milling, pelleting, cooking, fermentation, extrusion, expansion, toasting, chopping, grinding).

3. Requirements

The gatekeeper company must carry out a risk assessment of the supplier and the supply chain of the feed product in accordance with the HACCP principles.

This protocol applies except for the feed materials from the countries listed below :

Processed feed materials Countries

All processed feed materials Germany, Netherlands, Belgium, Luxembourg, United Kingdom, Austria

Fishmeal Peru

Oil seeds meals and citrus pulp Brazil

Oil seeds meals Argentina

Molasses Pakistan

Palm kernel expellers Malaysia

Palm kernel expellers Indonesia

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This protocol can be applied only by manufacturer.

Sampling is mandatory batch by batch.

Analyses have to be performed on each batch for the parameters reported in the next table.

Records and other documentation related to the application of this protocol must be documented. This must

be available for the auditor and – if requested – for the scheme owner.

This includes the following :

- Raw feed materials, production methods, process flow and environment from which the feed is

derived, necessary for the risk assessment,

- Name and address data of the non-certified producer

- Name of the purchase feed materials,

- Record of each batch purchased,

- Results of risk and lab analysis

- Any other relevant data.

In application to the HACCP principles, the lack of one or more requested information listed above could conduct to define additional control and monitoring measures.

The gatekeeping company informs its CB and OQUALIM (by email: [email protected]) of the use of this protocol for each new processed feed material including its type and origin.

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Table of the required parameters to be analyzed for processed feed materials in this protocol

Parameter

Processed feed materials

Dioxins and

PCB DLPCB NDL PAHs

Pesticide

residues

4 Heavy metals

(As,Cd,Pb,Hg)

5 Heavy metals

(As,Cd,Pb,Hg,F)Nickel Aflatoxin B1 DON ZEA Fumonisins OTA T2/HT2 Salmonellas Clostridium sp.

Hydrocianic

acidAntibiotics Metanol

Insoluble

impurities

Cereal grains and (by-)productsX X X X X X X X

a X

(By-)products of oil seeds, oil

fruits, oil supplying plantsX X X X X X X X (linseed)

Legumes, their products and by-

products X c X c X c X X X

(By-)Products from maize starch

productionX X X X X

b X X Xb X X

(By-)Products from wheat starch

productionX X X X X X X X

(By-)Products from potato starch

productionX X X c X X X (proteins)

X if delivered

directly to farmer

(By-)Products from sugar

productionX X X c X X X X

(By-)Products from beer

production

X c X c X X XX (yeast if process

unkwown)

(By-)Products from maltingX X X X X X X X

Brewers'grainsX X X X X X X X

Minerals miningX X X

(by)Products from milk

production

X fatty

products

X fatty

productsX X

Glycerine as (by-)product from

seed oil productionX X X X X X

Dried grass mealX X X X X X

(By-)Products from fruit

processingX X X X X

X almond

and apricot

X almond

and apricot

Feed fats and oils (including

animal fats)X X

X vegetable

oilX X fat only

X animal fat

only

Fish, marine animals and (by-

)products

X X X X X XX Fish and shrimp

from non EU

countries only

a : only for oat and oat products

b : only for maize and maize products

c: if artificially dried only

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Appendix 2: Guidelines of the Codex for the application of the HACCP system

1. Set up the HACCP team The entrepreneur must ensure that he/she has experts and technicians specialising in the product in order to set up an effective HACCP plan. In principle, he/she must set up a multidisciplinary team for this purpose. If such specialists are not available on-site, they must be sought elsewhere. The scope of the HACCP plan must be defined. This scope must describe the segment of the concerned food chain as well as the general hazard classes to be covered (for example, coverage of all hazard classes or only certain hazards). 2. Describe the product A full description of the product must be prepared, including instructions with regard to safety of use, such as composition, physical/chemical structure (including AW, pH, etc), microbicide/static treatments (for example heat treatments, freezing, brine, salting, etc), packaging, durability, storage conditions and distribution methods. 3. Determine the planned use The use to which the product is destined must be defined according to the user or final consumer. In some cases, it may be necessary to take into account vulnerable population groups (for example collective catering). 4. Prepare an operations diagram The HACCP team is responsible for preparing this diagram, including all operation steps. By applying the HACCP system to a given operation, all stages prior to and after the operation must be taken into account. 5. Confirm the operations diagram on-site The HACCP team must constantly compare the execution of the activities on the operations diagram and, if applicable, amend the latter. 6. List the potential hazards related to each of the steps, conduct a risk analysis and define the measures to control the identified hazards (See Principle 1). The HACCP team must list all of the hazards that can reasonably be expected at each of the steps - primary manufacturing, transformation, manufacturing, distribution and final consumption. The HACCP team must then conduct a risk analysis, in order to identify all of the hazards which require elimination, or bring them to an acceptable level, if safe food is to be obtained. When a risk analysis is conducted, the following factors must, as far as possible, be taken into account: probability that a hazard occurs and the seriousness of its consequences on health; qualitative and/or quantitative assessment of the presence of hazards; survival or proliferation of hazardous micro-organisms; appearance or persistence in feed of toxins, chemical substances or physical agents; factors causing the above. The HACCP team must envisage possible measures to apply in order to control each hazard. Several interventions are sometimes required to control a specific hazard and several hazards may be controlled using the same intervention. 7. Identify the critical control points (see Principle 2)

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There may be more than one CCP where a control operation is applied for the same hazard. The identification of a CCP as part of a HACCP system may be facilitated by the application of a decision tree (for example Diagram 2) with reasoning based on logic. Some flexibility should be used in applying decision trees, depending on whether the operation concerns manufacturing, slaughter, transformation, storage, distribution, etc. It must be used for information purposes when identifying the CCP.; The decision tree provided as an example does not necessarily apply to all situations. Other approaches may be used. Training is recommended to facilitate the application of decision trees. If a hazard is identified at a step where a safety control is required and where no intervention measures exist at this step or any other, the corresponding product or procedure must be modified at this step or at a prior or later step, in order to provide for an intervention. 8. Establish critical limits for each CCP (see Principle 3) It is necessary to set and validate if possible, limits corresponding to each of the critical points for hazard control. In some cases, several critical limits are set for a given step. The criteria selected can include temperature, duration, humidity level, pH, percentage of free water and available chlorine, as well as organoleptic parameters such as the appearance to the naked eye or the consistency. 9. Set up a monitoring system for each CCP (see Principle 4) Such a monitoring system enables the measurement or observation of the critical limits corresponding to the CCPs. The procedures applied must be able to detect any loss of control. Moreover, data must be communicated at the right time to conduct the necessary adjustments, in order to avoid exceeding the critical limits. As far as possible, procedure adjustments must be made when the monitoring results indicate a trend towards a loss of control at a CCP. These adjustments must be conducted before a deviation occurs. The obtained data must be assessed by a person expressly appointed for this purpose with the necessary knowledge and authority to implement corrective measures if required. If the monitoring is not continuous, the controls exercised must be sufficiently frequent and in-depth to guarantee CCP control. Most of these controls must be conducted rapidly, as they cover the manufacturing chain and there is insufficient time to conduct long-term analyses. It is generally preferable to note the physical and chemical parameters rather than conduct microbiological tests, as these are faster and often also indicate the product's microbiological state. All readings and notes resulting from CCP monitoring must be signed by the person(s) responsible for the monitoring operations, as well as by one or several company managers. 10. Establish corrective action (see Principle 5) Specific corrective actions must be provided for each CCP as part of the HACCP system to rectify deviations if they occur. These actions must guarantee that the CCP has been controlled. They must also provide for the outcome reserved for the incriminated product. The actions taken must be indicated in the HACCP registers. 11. Apply verification procedures (see Principle 6) We may use methods, procedures, verification and audit tests, notably sampling and the analysis of random samples, to determine whether the HACCP system is functioning correctly. Such controls must be sufficiently frequent to confirm the correct functioning of the system. For example, you must: - review the HACCP system and the supporting files; - take note of any deviations and the outcome for the product; - verify that the CCPs are correctly controlled. As far as possible, the validation measures should include activities to confirm the effectiveness of all items of the HACCP plan.

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12. Constitute files and keep records (see Principle 7) Precise, rigorous record keeping is essential to the application of an HACCP system. HACCP system procedures must be documented and be suited to the type and scale of the operation. Examples of files: - Hazard analysis; - Identification of the CCP; - Identification of the critical limit. Examples of registers: - CCP monitoring activities; - Difference and related corrective actions; - Amendments to the HACCP system.